The bipolar disorder (BD) market is highly genericized, consisting of antipsychotics, anticonvulsants, and mood stabilizers such as lithium. The atypical antipsychotic market is the most dominant of the drug classes indicated for BD, and the oral atypical antipsychotic market is highly competitive with many generic alternatives available. Bipolar patients are typically on more than one drug for the treatment of their symptoms because of the complexity of the disease, including the cycling between manic and depressive phases. Mood stabilizers, such as lithium and valproate, tend to be the first line of therapy in the US, followed by antipsychotics such as risperidone, aripiprazole, and olanzapine, and some patients also require low dose antidepressants. For maintenance treatment, if a patient is tolerating a certain drug, such as risperidone, then they will continue on it, but if the patient has issues with tolerability, they are normally switched to an alternative with a more benign metabolic profile or a better safety profile. 

The most recent events to have occurred in the BD space include the FDA approvals of Lundbeck’s Abilify Asimtufii (aripiprazole two-month) and Luye Pharma’s Rykindo (extended-release risperidone microspheres for intramuscular injection), as well as Phase III data releases for Intra-Cellular’s Caplyta and Vanda Pharmaceuticals’ Fanapt. An sNDA for Fanapt in adults with bipolar I disorder was submitted to the FDA in November 2023. 

This Datamonitor Healthcare report contains a Disease Analysis module.